ABSTRACT
This chapter will define and provide an overview of the drug safety toxicology process. It will describe its evolution, development, and reliance on the interface between the cutting edge, validated and adopted, widely accepted methodologies and the application of sound principles of drug evaluation and review that allow these methods to be used as effective tools to predict toxicity and maximize drug safety. The ensuing discussion will describe the path that a new method or scientific approach should take to successfully evolve into what is normally considered to be a ‘‘gold standard’’ tool in the drug safety armamentarium. It will also include a description of the various stages at which completely new methods moving into ascendancy are, and contrast these with those methods that are no longer widely accepted or routinely used and the reasons for their decline. Finally, this chapter will highlight several widely accepted methods, and some of the most promising recent approaches to drug safety toxicology, as well as some of the newest frontiers and their potential for innovative changes to drug toxicology. The effective utilization of drug safety toxicology is the bridge between resource and time intensive drug development and a better quality of life for those who are the beneficiaries of approved, safe, and effective therapeutic agents.
